All study participants received the standard treatment of induction chemotherapy and chemo-radiation. Patients were randomized to receive either shark cartilage or placebo, both in the form of a liquid. Patients drank four ounces of the extract twice daily, and continued on the shark cartilage/placebo as maintenance after completing standard therapy.
Researchers say that the study did not meet its primary endpoint: survival. With a median follow-up of 3.7 years, researchers did not find a statistical difference in survival between patients who received the shark cartilage, 14.4 months, and those who received the placebo, 15.6 months.
"Clearly, these results demonstrate that AE-941 is not an effective therapeutic agent for lung cancer," said Lu. "So, too, these findings have to cast major skepticism on shark cartilage products that are being sold for profit and have no data to support their efficacy as cancer-fighting agent."
Patients who are currently taking shark cartilage should be very cautious in accepting that the therapy will be beneficial, warns Lu.
"We have absolutely no data showing improvements in survival, tumor shrinkage and/or clinical benefits to patients," said Lu. "Now when patients ask their oncologists about shark cartilage, physicians can point to this large NCI-sponsored Phase III trial and tell patients that, at this point, the only studies that have been done with cartilage-derived products have been negative."
Lung cancer is the leading cancer killer in both men and women; according to the American Cancer Society, approximately 219,440 were diagnosed with lung cancer in 2009 and 159,390 died from the disease.
Non-small cell is the most common type of the disease, accounting for about 80 percent of all lung cancers, said Lu.
|Contact: Scott Merville|
University of Texas M. D. Anderson Cancer Center